Regulatory Manager

Balchem Corporation; Montvale (NJ); Vor Ort; USD 120.000 - 190.000; Vollzeit

Zusammenfassung

Balchem Corporation in Montvale, NJ seeks a Manager, Regulatory to partner with R&D, Marketing and Quality to guide regulatory strategy, enable market access, and support global expansion. You will lead regulatory submissions, monitor developments, and advise cross-functional teams on labeling, claims, and compliance to drive product commercialization.

The role requires a Master’s or PhD and 8-10+ years of regulatory affairs, with strong communication and project-management skills.

Qualifikationen

• Master's degree or Ph.D. in a related scientific discipline.
• 8-10+ years of progressive regulatory affairs experience.
• Experience supporting product commercialization, innovation initiatives, and global expansion.
• Experience developing regulatory strategies for new products, ingredients, or claims.
• Ability to influence stakeholders and manage multiple priorities.

Aufgaben

• Serve as a trusted regulatory advisor to business partners and cross-functional teams on market access, product positioning, regulatory risk, and commercialization opportunities.
• Provide regulatory insight to support strategic planning, portfolio management, and business development initiatives.
• Assess emerging regulatory developments and advise stakeholders on potential business impacts, opportunities, and risks.
• Support integration activities associated with acquisitions, partnerships, and other strategic initiatives.
• Partner with R&D and commercial teams to establish regulatory pathways for new products, ingredients, technologies, and claims.
• Advise cross-functional teams on regulatory implications of emerging technologies and business opportunities.
• Evaluate regulatory requirements and market access pathways for new geographic markets.
• Monitor changes in U.S. and global regulatory environments and recommend actions to maintain market access and growth.
• Oversee regulatory submissions, registrations, and authorization activities.

Kenntnisse

Regulatory affairs

Regulatory strategy

Cross-functional collaboration

Project management

Global market access

Ausbildung

Master's or PhD in Food Science, Chemistry, Toxicology, Regulatory Science, Nutrition, Biochemistry, Pharmaceutical Sciences

Jobbeschreibung

Company Overview

Balchem is committed to making the world a healthier place by delivering trusted, innovative, and science-based solutions for the health and nutritional needs of the world. Balchem employs approximately 1,400 employees worldwide who provide the service, quality, and technology that enables our customers to win with their customers. We have built a reputation for delivering results to all of our stakeholders. Founded in 1967, Balchem, a Maryland corporation, became a publicly-traded company in 1970 and is listed on Nasdaq under the symbol “BCPC.” Our corporate headquarters is located in Montvale, New Jersey, and we have a broad network of sales offices, manufacturing sites, and R&D centers, primarily located in the U.S. and Europe. The Company consists of three business segments: Human Nutrition and Health, Animal Nutrition and Health, and Specialty Products.

Position Summary

The Manager, Regulatory role serves as a strategic regulatory partner supporting Balchem’s businesses. This role is responsible for providing regulatory guidance and support that enable business growth, accelerate innovation, facilitate entry into new markets, and strengthen competitive positioning. Working closely with R&D, Marketing, Quality, Supply Chain, Legal, and other functions, this individual translates complex regulatory requirements into practical business solutions that support product development, commercialization, portfolio expansion, and global market expansion.

Essential Functions

Strategic Regulatory Partnership

• Serve as a trusted regulatory advisor to business partners and cross-functional teams on market access, product positioning, regulatory risk, and commercialization opportunities.
• Provide regulatory insight to support strategic planning, portfolio management, and business development initiatives.
• Assess emerging regulatory developments and advise stakeholders on potential business impacts, opportunities, and risks
• Support integration activities associated with acquisitions, partnerships, and other strategic initiatives.

Innovation and Commercialization Support

• Partner with R&D and commercial teams to establish effective regulatory pathways for new products, ingredients, technologies, and claims.
• Provide strategic regulatory guidance throughout product development and commercialization activities.
• Identify opportunities to leverage regulatory frameworks to support competitive differentiation and market access.
• Contribute regulatory expertise to the innovation pipeline reviews and stage-gate processes.
• Advise cross-functional teams on regulatory implications of emerging technologies, product concepts, and business opportunities.

Global Market Expansion

• Evaluate regulatory requirements and market access pathways for new geographic markets.
• Help develop regulatory strategies to support global product registrations, authorizations, and commercialization activities.
• Collaborate with cross-functional teams, regulatory consultants, trade associations, and external stakeholders to support business objectives.
• Monitor changes in U.S. and global regulatory environments and recommend actions to support continued market access and growth.

Regulatory Compliance and Operational Excellence

• Provide expert guidance regarding regulatory requirements applicable to Balchem products and technologies.
• Oversee regulatory submissions, registrations, and authorization activities, ensuring alignment with business priorities.
• Review product claims, labeling, technical documentation, and marketing materials for regulatory compliance.
• Support the development and continuous improvement of regulatory processes, systems, and best practices.
• Maintain awareness of U.S. and global regulatory developments and communicate relevant business implications to stakeholders.
• Manage relationships with external regulatory consultants and service providers as needed.

Collaboration and Technical Expertise

• Build strong partnerships with internal stakeholders across multiple business functions.
• Influence decision-making through clear communication of regulatory requirements, risks, and opportunities.
• Share regulatory knowledge and best practices with colleagues and project teams.
• Serve as a subject matter expert for complex regulatory matters affecting assigned businesses and product portfolios.

Requirements

• Master's degree or Ph.D. in Food Science, Chemistry, Toxicology, Regulatory Science, Nutrition, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline.
• 8-10+ years of progressive regulatory affairs experience.
• Demonstrated success supporting product commercialization, innovation initiatives, and global market expansion
• Experience developing regulatory strategies for new products, ingredients, technologies, or claims.
• Experience working effectively with cross-functional teams and senior stakeholders
• Experience managing complex regulatory projects and working with external consultants or regulatory agencies.
• Deep understanding of regulatory frameworks relevant to Balchem's products and markets.
• Strong business acumen and ability to align regulatory strategies with commercial objectives.
• Ability to interpret complex regulatory requirements and translate them into practical business recommendations.
• Excellent written, verbal, and presentation skills.
• Strong project management, organizational, and analytical abilities.
• Ability to influence stakeholders and build effective working relationships across functions and geographies.
• Demonstrated ability to manage multiple priorities in a dynamic business environment.